Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0057—Pumps therefor
  • A61M16/0066—Blowers or centrifugal pumps
  • A61M16/0069—Blowers or centrifugal pumps the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
  • A61M16/022—Control means therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/20—Valves specially adapted to medical respiratory devices
  • A61M16/201—Controlled valves
  • A61M16/202—Controlled valves electrically actuated
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/20—Valves specially adapted to medical respiratory devices
  • A61M16/201—Controlled valves
  • A61M16/206—Capsule valves, e.g. mushroom, membrane valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/20—Valves specially adapted to medical respiratory devices
  • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/10—Preparation of respiratory gases or vapours
  • A61M16/12—Preparation of respiratory gases or vapours by mixing different gases
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/0015—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
  • A61M2016/0018—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
  • A61M2016/0021—Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical with a proportional output signal, e.g. from a thermistor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
  • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
  • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
  • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
  • A61M2016/0039—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the inspiratory circuit

Definitions

• the present invention relates to a respiratory assistance device, commonly called a ventilator, which can be used in the context of respiratory assistance at home or in a hospital environment.
• respiratory assistance consists of ventilating a patient using a pressurized gas, for example air or oxygen-enriched air, that is to say to apply during the inspiratory phase. , usually initiated by the patient, a constant positive pressure in the "patient" circuit of a respiratory system.
• a pressurized gas for example air or oxygen-enriched air
• the "patient” circuit or inspiratory branch usually consists of channeling elements making it possible to connect the patient's airways with the source of gas under pressure; the patient circuit therefore includes elements, such as the respiratory tract (s), a mask or breathing goggles, a tracheostomy probe.
• the pressure in the patient circuit varies depending on the respiratory phase: inspiratory phase or expiratory phase.
• a gas flow source such as, for example, a turbine or a compressor
• PEEP pressure given positive expiratory
• Exhalation of exhaled gases is usually carried out through either one (or more) exhalation valve fitted on the patient circuit, or through holes or gills fitted in the respiratory mask.
• Respiratory devices operating on this principle are commonly called two-level respiratory devices.
• Respiratory assistance devices with two pressure levels fitted with one or more exhalation valves are therefore preferred.
• EP-B-0317417 which describes a breathing assistance device in which the patient circuit includes an expiration valve with pneumatic control.
• the control input of this valve is subjected to the pressure of a pressurized flow source, which closes the exhalation valve and makes it possible to tightly connect the patient circuit with said pressurized gas flow source.
• control electronics completely interrupt the operation of the pressurized flow source, whose structure is such that its outlet orifice is then reduced to atmospheric pressure, which pressure is applied to the exhalation valve, allowing it to open.
• EP-A-0425092 relates to a breathing aid device comprising, in place of the exhalation valve, a permanent, calibrated leak orifice, while the pressure of the pressure is adjusted at two different levels a flow source, depending on whether you are in the inspiration or expiration phase.
• WO-A-94/06499 further describes a breathing aid device comprising a patient circuit having a inspiratory branch connected to a source of pressurized inspiratory flow and an expiratory branch, in which is installed an exhalation valve controlled to be closed during inspiration.
• EP-A-839 545 describes a respiratory assistance device comprising an inspiratory branch permanently connected, at its upstream end, to a first source of flow of gas under pressure and, at its downstream end, to the respiratory tract of a user, at least first and second expiratory valves arranged on said respiratory branch controlled to be closed during the inspiratory phase, a detection means detecting, near the downstream end of the inspiratory branch, l respiratory activity of the user and transmitting respiratory activity data to control means, said control means controlling the first source of gas flow so as to deliver, in the inspiratory branch, a flow of gas with non-flow null and appreciably constant throughout the expiratory phase.
• the control means control the first source of gas flow so as to deliver, in the inspiratory branch, a gas flow whose flow, during an expiratory phase, is substantially equal to the flow delivered at the end of the previous inspiratory phase.
• a second flow source not connected to the first flow source and controlled by said control means, makes it possible to control the opening of the pneumatic valves during the expiratory phase.
• the electro-pneumatic elements used to generate the flows or pressures of respiratory gas are usually compressors, turbines or motorized bellows.
• motorized bellows are not reliable sources of pressure, in particular because of their poor ability to compensate for gas leaks occurring on the patient circuit.
• compressors are, in general, of a size and an electrical consumption incompatible with the compactness and the autonomy expected from such a device, in particular when this device is intended for use at home or to be placed on a wheelchair or the like.
• the object of the present invention is therefore to propose a respiratory assistance device not presenting the abovementioned problems, namely a device capable of compensating for leaks, of maintaining a flow rate.
• a respiratory assistance device not presenting the abovementioned problems, namely a device capable of compensating for leaks, of maintaining a flow rate.
• high respiratory gas even in the presence of a significant back pressure, which allows to maintain a non-zero ventilation of the patient even in case of failure of the main source of respiratory gas and / or which has a compactness and / or a compatible autonomy both with hospital and home use.
• the present invention therefore relates to a respiratory assistance device comprising:
• At least one inspiratory branch connecting means for supplying respiratory gas to the respiratory tract of a user said means for supplying respiratory gas comprise at least a first source of respiratory gas and at least a second source of respiratory gas, said first and second sources being pneumatically connected in series during at least part of at least one inspiratory phase,
• the inspiratory branch comprising a secondary valve and an expiratory valve, the opening and closing of which are ensured by pneumatic balloons or membranes
• - switching means comprising two solenoid valves EV1, EV2 controlled by control means 16 making it possible to connect , in a substantially sealed manner, said first and second sources of respiratory gas, pneumatically connected in series, to said inspiratory branch and to make said inspiratory branch pneumatically sealed, during at least part of at least one inspiratory phase, by acting on said pneumatic balloons or said membranes of said secondary valve and expiratory valve to allow supply of said inspiratory branch with respiratory gas, and
• an annex branch comprising gas conduits and said two solenoid valves EV1, EV2 which are controlled by the control means.
• Pulmatically connected or connected in series means that one of the two sources of respiratory gas delivers pressurized breathing gas to or from the other source of breathing gas.
• the device of the invention may include one or more of the following characteristics:
• the first and second sources of respiratory gas are motorized, preferably motorized turbines.
• the first and second sources of respiratory gas are turbines with low inertia, for example turbines having an adjustable rotation speed of between 5,000 and 25,000 rpm and / or a turbine diameter of less than 100 mm, preferably less than 80 mm, as described for example in document FR-A-2663547.
• the electronic control means are of analog and / or digital type, for example one or more microprocessors or microcontrollers.
• Said piloting means control said first and second sources of respiratory gas independently of one another.
• auxiliary gas source connected to said inspiratory branch via at least one auxiliary circuit comprising at least one auxiliary valve, preferably, said auxiliary valve is controlled by said control means, so as to periodically or continuously inject an auxiliary gas into said inspiratory branch conveying respiratory gas, advantageously, a non-return valve or similar means is arranged so as to protect the first and second sources of respiratory gas by avoiding any untimely rise of auxiliary gas to said first and second gas sources;
• - It further comprises at least one pressure sensor and / or at least one flow sensor arranged on said inspiratory branch and cooperating with said control means. it further comprises a pressure balancing line or branch. - the pressure balancing line or bypass tends to balance the pressures prevailing: . either, on the one hand, in the fourth conduit connecting the inspiratory branch and the annex branch and, on the other hand, in the third conduit connecting the portion of inspiratory branch connecting the first and second sources of respiratory gas, one to the other, and the second conduit;
• the invention further relates to a method of controlling a respiratory assistance device according to the invention for the supply of a respiratory gas or gas mixture to the upper airways of a user, said device respiratory assistance including:
• At least one inspiratory branch connecting means for supplying respiratory gas to the respiratory tract of a user means for supplying respiratory gas comprising at least first and second sources of respiratory gas arranged in series, in particular motorized turbines ,
• - piloting means in which at least part of at least one inspiratory phase is supplied, at least the inspiratory branch with respiratory gas delivered by said first and second sources of gas, said first and second sources of gas being pneumatically connected in series during at least part of at least one inspiratory phase.
• the method of the invention may include one or more of the following characteristics:
• - we adjust or maintain a breathing gas flow in the inspiratory branch less than or equal to 200 l.mi and / or we adjust or maintain a breathing gas pressure in the inspiratory branch less than or equal to 12000 Pa, preferably lower or equal to 8000 Pa, in acting on the first and / or second sources of respiratory gas arranged in series.
• the respiratory gas is chosen from gas mixtures containing nitrogen and at least 15% oxygen, in particular air or air enriched with oxygen, optionally supplemented with one or more annex gases, in particular nitrogen monoxide (NO), helium, carbon dioxide or an anesthetic gas.
• nitrogen monoxide NO
• helium helium
• carbon dioxide or an anesthetic gas.
• said first and second sources of respiratory gas are controlled independently of one another.
• FIG. 1 represents the diagram of a first embodiment of a respiratory assistance device according to the present invention, which comprises a first and a second source of respiratory gas, which here are two turbines T1 and T2 arranged in series and delivering a respiratory assistance gas, for example compressed air, into the inspiratory branch 7 or patient circuit, which inspiratory branch 7 routes the respiratory assistance gas to the upper airways of a patient P 1 (not shown).
• a respiratory assistance gas for example compressed air
• connection between the inspiratory branch or patient circuit 7 and the patient P ' is carried out by means of a nasal and / or buccal piece, such as a mask 14 or the like.
• the inspiratory branch 7 comprises two valves 10 and 11, namely a secondary valve 10 and an exhalation valve 11, the opening and closing of which are controlled by pneumatic balloons 12 and 13 or the like, for example membranes.
• the flow rate D and pressure P sensors are arranged on said inspiratory branch 7 and are connected, via the links 50 and 51, respectively, to electronic control means 16 of analog and / or digital type, so as to supply these control means 16 for flow and / or pressure information, respectively.
• this assistance device also includes an annex branch 17 comprising first, second, third, fourth and fifth gas conduits 1 to 5, respectively, and two solenoid valves EV1 and EV2. As seen in the figures:
• the second conduit 2 corresponds to the portion of the annex branch 17 located between the solenoid valves EVl and EV2, the fourth conduit 4 connects the inspiratory branch 7, from a site located between the second turbine T2 and the valve 10, to branch annex 17, via the EV2 solenoid valve,
• the third conduit 3 connects the inspiratory branch portion 7 'connecting the first and second sources Tl and T2 of respiratory gas, one to the other, to said second conduit 2 via the solenoid valve EVl.
• solenoid valves EV1 and EV2 are also controlled, via links 55 and 56, respectively, by the control means 16, which control means 16 also control, via links 54 and 53, the flow rate and / or the pressure of the gas delivered by each of the turbines Tl and T2, respectively.
• the turbines Tl and T2 are regulated in flow rate and / or in pressure as a function of the ventilation mode selected and on the basis of the flow rate and / or pressure values measured by the flow sensor D and / or the pressure sensor. P.
• control means 16 control the solenoid valve EVl so as to connect the third and second conduits 3 and 2, which implies, on the one hand, that the gas delivered by the turbine Tl cannot escape to the atmosphere via the first conduit 1 and, on the other hand, that the third conduit 3 and the second conduit 2 are under pressure; however, the second conduit 2 does not communicate with the annex branch 17.
• control means 16 also control the electrovalve EV2 so as to put the fourth conduit 4 and the branch 17 into communication, and therefore also the patient circuit or inspiratory branch 7 and the branch 17 via said fourth conduit 4.
• the pressure of the patient circuit 7 delivered by T1 and T2, which are connected in series, is then transmitted to the balloons 12 and 13 of the secondary 10 and expiratory 11 valves, respectively, and this, by by means of said fourth conduit 4 and of annex branch 17, which has the effect of inflating the balloons 12 and 13 and of closing these valves 10 and
• the pressurized breathing gas is then conveyed by the inspiratory branch 7 to the patient P ', since the inspiratory branch 7 is closed in a sealed manner, since the valves 10 and 11 are closed, thus preventing escape to the atmosphere, by said valves 10 and 11, of the gas carried by inspiratory branch 7.
• an auxiliary gas source 20 for example an oxygen source, is connected to the inspiratory branch 7 by means of an auxiliary circuit 9 comprising an electrovalve EV3 and a non-return valve 15.
• the EV3 valve or auxiliary valve is controlled by said control means 16, via a link 52, so as to periodically inject an auxiliary gas, for example oxygen, into said inspiratory branch 7 conveying the respiratory gas to the patient P '.
• an auxiliary gas for example oxygen
• the turbines Tl and T2 are regulated in flow rate by the control means 16, that is to say that the flow rate of each of the two turbines Tl and T2 adapts to the value of total desired flow from which the flow of oxygen injected by the auxiliary source is subtracted 20.
• the valve EV3 of the auxiliary circuit 9 is controlled by the means pilot 16 so as to stop or limit the supply of auxiliary gas and thus avoid overpressures in the inspiratory branch 7.
• the EV1 solenoid valve is controlled, via the link 55, by the control means 16 so as to connect the third and second conduits 3 and 2, and the EV2 solenoid valve is controlled, via the link. 56, so as to connect the second conduit 2 and the annex branch 17.
• the turbine Tl makes it possible to maintain, via the annex branch 17, a determined pressure in the balloons 12 and 13 of the secondary 10 and expiratory valves 11, respectively, so as to reduce the gas leakage through these valves 10 and 11, and thus maintain the pressure of the inspiratory branch 7 at the desired value during expiration, that is to say at a positive expiratory pressure or PEP.
• the control voltage of the turbine T2 is moreover kept substantially constant and a flow of respiratory gas escapes through the valves 10 and 11, respectively.
• this auxiliary gas escapes during the expiration by the valve 11 arranged, preferably, near the interface 14, for example a breathing mask, or a tracheostomy or intubation probe.
• a non-return valve 31 or similar means is arranged downstream of the inspiratory valve 10, as shown diagrammatically in FIG. 1. If the desired PEEP value is zero, then 1 • EVl solenoid valve is controlled by the control means 16 so as to connect the second and first conduits 2 and 1, and the solenoid valve EV2 is controlled in order to connect the second conduit 2 and the branch branch 17 so as to escape from the atmosphere the gas under pressure contained in the annex branch 17 and, thereby, obtain complete deflation of the balloons 12 and 13 of the secondary 10 and expiratory valves 11, respectively, which cancels or reduces the pressure prevailing in the inspiratory branch 7, 1 • excess pressure, that is to say gas, being evacuated to the atmosphere by said valves 10 and 11.
• turbines T1 and T2 are controlled so as to maintain their speed at a given value making it possible to reduce their response time at the start of the next inspiration phase.
• the gas flow delivered by these turbines Tl and T2 escapes through the valves 10 and 11, and the oxygen flow coming from the auxiliary source 20 possibly present escapes through the valve 11.
• the balancing line 5 allows to achieve an equalization of the respective speeds of the turbines T1 and T2.
• the two turbines Tl and T2 have, permanently, substantially the same rotational speeds so that they age and wear out slower otherwise, if for example the second turbine brakes the first turbine by turning less quickly it, the wear of the first turbine will be faster than that of the second turbine.
• Figure 2 shows schematically an alternative embodiment of the device according to the invention almost identical to that of Figure 1, with the exception that, as shown in the FIG. 2, the balancing line or branch 5 intended to balance the pressures prevailing, on the one hand, in the fourth conduit 4 connecting the inspiratory branch 7 and adjoining branch 17 and, on the other hand, in the third conduit 3 connecting the portion 7 ′ of the inspiratory branch 7 connecting the first and second sources T1, T2 of respiratory gas, one to the other, and in the second conduit 2.
• the balancing line or branch 5 intended to balance the pressures prevailing, on the one hand, in the fourth conduit 4 connecting the inspiratory branch 7 and adjoining branch 17 and, on the other hand, in the third conduit 3 connecting the portion 7 ′ of the inspiratory branch 7 connecting the first and second sources T1, T2 of respiratory gas, one to the other, and in the second conduit 2.
• a restriction 30 is added, for example a calibrated orifice, on the conduit 3 in order to better control the pressure of the balloons 12 and 13 when it is desired to regulate a non-zero pressure in the circuit 7 , upon expiration.
• the bypass line 5 therefore retains exactly the same function in the two embodiments ( Figures 1 and 2) but its position according to Figure 2 allows better control of the pressure in the balloons 12 and 13 during expiration, in all cases, while always equalizing the speeds of the turbines and thus avoiding their premature wear.
• a device according to the present invention has an indisputable advantage compared to conventional devices, given that, in the event of failure of one of the two flow sources Tl or T2, the remaining flow source ensures ventilation at patient's minimum minimum.
• the ventilation device of the invention can be used to treat respiratory insufficiencies of any type, in particular those resulting from restrictive diseases, in particular neuromuscular, such as myopathy, or obstructive, such as chronic obstructive pulmonary disease or emphysema.

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• Health & Medical Sciences (AREA)
• Pulmonology (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Emergency Medicine (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Respiratory Apparatuses And Protective Means (AREA)

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Applications Claiming Priority (2)

Publications (1)

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Cited By (4)

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Citations (7)

• 1998
  • 1998-10-12 FR FR9812737A patent/FR2784297B1/fr not_active Expired - Fee Related
• 1999
  • 1999-10-12 AU AU60951/99A patent/AU6095199A/en not_active Abandoned
  • 1999-10-12 JP JP2000575568A patent/JP2002527152A/ja active Pending
  • 1999-10-12 EP EP99947542A patent/EP1121169A1/fr not_active Withdrawn
  • 1999-10-12 WO PCT/FR1999/002448 patent/WO2000021596A1/fr not_active Application Discontinuation

Patent Citations (7)

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